Cleared Traditional

K081063 - SENSITITRE YEASTONE SUSCEPTIBILITY PLAT...

K081063 is the FDA 510(k) clearance for SENSITITRE YEASTONE SUSCEPTIBILITY PLAT... by Trek Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code NGZ) cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K081063 · Trek Diagnostic Systems, Inc. · Microbiology device
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Mar 2009
Decision
326d
Days
Class 2
Risk

K081063 is an FDA 510(k) clearance for the SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS. Classified as Susceptibility Test Plate, Antifungal (product code NGZ), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 6, 2009 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Trek Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K081063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date March 06, 2009
Days to Decision 326 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 102d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGZ Susceptibility Test Plate, Antifungal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - NGZ Susceptibility Test Plate, Antifungal

All 18
Devices cleared under the same product code (NGZ) and FDA review panel - the closest regulatory comparables to K081063.
VITEK 2 YEAST CASPOFUNGIN
K101566 · bioMerieux, Inc. · Sep 2010
VITEK 2 YEAST VORICONAZOLE
K092454 · bioMerieux, Inc. · May 2010
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K090968 · Trek Diagnostic Systems, Inc. · Jun 2009
VITEK 2 AST-YS FLUCONAZOLE
K061945 · bioMerieux, Inc. · Sep 2006
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
K040560 · Ab Biodisk · Jul 2004
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
K991810 · Trek Diagnostic Systems, Inc. · Oct 2001